Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint|
- swelling of hip joint [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluatin the swelling of hip joint by physical examination after intra articular injection.
- deterioration of joint function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluation deterioration of joint function by physical examination after intra articular cell injection.
- skin allergic reaction [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
- Respiratory reaction [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.
- Quantitative changes in pain intensity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)
- physical function improvement [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
- subchondral bone edema [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Evaluation the subchondral bone edema by MRI
- cartilage thickness [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]measuring the cartilage thickness after cell transplantation by MRI
|Study Start Date:||June 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: hip osteoarthritis
The patients with hip joint osteoarthritis who underwent cell injection
Biological: stem cell injection
intra articular inection of mesenchymal stem cell
This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499056
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of Royan Cell therapy Center|
|Principal Investigator:||Mohsen Emadeddin, MD||scientist|